Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting
Conditions
Keywords
Ginger, Postoperative Nausea and Vomiting, Laparoscopic Cholecystectomy
Brief summary
This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after laparoscopic cholecystectomy.
Interventions
Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy
Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥ 18 years. * Scheduled for elective laparoscopic cholecystectomy under general anesthesia. * American Society of Anesthesiologists (ASA) physical status I-III. * Able to understand the study procedures and provide written informed consent.
Exclusion criteria
* Known allergy or hypersensitivity to ginger * Documented history of bleeding disorders or current treatment with anticoagulant agents * History of severe postoperative nausea and vomiting or an Apfel score of 4 * Administration of antiemetic drugs or corticosteroids during the preoperative period * Pregnancy or breastfeeding * Active gastrointestinal or liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery | 2 hours after surgery. | Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of PONV beyond 2 hours postoperatively | From 2 hours to 24 hours after surgery. | Proportion of participants who experienced at least one additional episode of nausea or vomiting occurring after the 2-hour postoperative time point. |
| Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery | 24 hours after surgery. | Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery. |
| Total number of vomiting episodes | Within 24 hours post-surgery. | Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery. |
| Use of rescue antiemetics | 24 hours postoperatively | The need for rescue antiemetics within 24 hours postoperatively. |
| Incidence of ginger-related adverse events | Within 24 hours after surgery | Number of participants experiencing adverse events known to be associated with ginger, including gastrointestinal discomfort (heartburn, abdominal pain, bloating, diarrhea), bleeding, or allergic reactions in the 24 hours after surgery. |
Countries
Tunisia